Parkinson Disease (PD)Phase 2NCT07903038
Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation
A Phase 2 study testing Lemborexant 5 mg and Placabo in people with Parkinson Disease (PD) and Sleep Initiation and Maintenance Disorders, run by Beijing Tiantan Hospital.
Trial summary
This study tests whether lemborexant, an approved sleep medicine, can improve sleep and recovery in people with Parkinson's disease undergoing deep brain stimulation (DBS) surgery. Sleep problems are common around surgery and may worsen pain and slow recovery. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders, Deep Brain Stimulation
- What is being tested?
- Lemborexant 5 mg and Placabo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease scheduled for elective DBS surgery under general anesthesia
- Age 50-80 years
- ASA physical status I-III
- Preoperative sleep disturbance, defined as Pittsburgh Sleep Quality Index (PSQI) score > 5
- Signed informed consent
Who cannot join
- Hoehn-Yahr stage ≥ 4
- Chronic use of sedative-hypnotic medications
- Acute psychiatric illness
- Severe sleep apnea, COPD, severe daytime sleepiness (Epworth Sleepiness Scale [ESS] ≥ 16), or history of narcolepsy and/or cataplexy
- Severe hepatic or renal impairment
- Use of systemic moderate or strong CYP3A inhibitors and/or inducers within 1 week before surgery
- Any condition that, in the opinion of the principal investigator, precludes participation in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: A Randomized, Double-blinded, Placebo-controlled Clinical Trial
This study tests whether lemborexant, an approved sleep medicine, can improve sleep and recovery in people with Parkinson's disease undergoing deep brain stimulation (DBS) surgery. Sleep problems are common around surgery and may worsen pain and slow recovery. Participants will be randomly assigned to take lemborexant or a placebo the night before surgery. Researchers will compare anesthesia use, wake-up time, sleep quality (objective and subjective), pain, recovery, and blood markers. The study will show whether lemborexant is safe and helpful for this group.
- Conditions
- Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders, Deep Brain Stimulation
- Being tested
- Lemborexant 5 mg, Placabo
- Medical subject headings
- Parkinson Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 5 mgDrug
Participants will receive a single oral dose of lemborexant 5 mg tablet on the night before surgery.
PlacaboDrug
Participants will receive a oral dose of matching placebo tablet on the night before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant 5 mg | Experimental | Participants will receive a single oral dose of lemborexant 5 mg tablet on the night before surgery. Receives: Drug: Lemborexant 5 mg |
| Placebo | Placebo comparator | Participants will receive a single oral dose of matching placebo tablet on the night before surgery. Receives: Drug: Placabo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST) on the Night Before Surgery
Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band 8) during the night before deep brain stimulation surgery. TST is defined as the total duration of sleep from sleep onset to final awakening, reported in minutes.
Measured: Night before surgery
Secondary outcomes (11)
Perioperative subjective sleep quality
Perioperative subjective sleep quality will be measured using the Richards-Campbell Sleep Questionnaire (RCSQ) score. The RCSQ is a 5-item visual analog scale assessing sleep depth, latency, awakenings, return to sleep, and sleep quality. Each item scored 0-100, total score is the mean of 5 items, range 0-100, higher scores indicate better sleep.
Measured: Preoperative night (assessed at 8:00-10:00 AM on the day of surgery), Postoperative days 1-3 (assessed at 8:00-10:00 AM)
Postoperative objective sleep quality
Sleep parameters, including total sleep time and the duration of each sleep stage, will be measured using a wrist-worn sleep monitoring device.
Measured: Postoperative night 1 and night 3 (20:00 to 08:00 next day)
Time to Extubation
Time from the end of surgery to extubation, defined as removal of the endotracheal tube. Reported in minutes.
Measured: Immediately after surgery (single assessment)
Time to Awakening
Time from the end of anesthesia to the first response to verbal command. Reported in minutes.
Measured: Immediately after surgery (single assessment)
Perioperative Anxiety Visual Analog Scale (VAS-A) Score
Anxiety Visual Analog Scale (VAS-A) score. The VAS-A is a 100-mm horizontal line anchored at 0 (no anxiety) and 100 (worst possible anxiety). The participant marks a point on the line corresponding to their anxiety level. Higher scores indicate greater anxiety. VAS-A score assessed upon entry to the operating room (before induction of anesthesia) and 1 hour after surgery.
Measured: Perioperative [Upon entry to the operating room (before induction of anesthesia) and 1 hour after surgery]
Postoperative Hospital Anxiety and Depression Scale (HADS) Score
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-rated questionnaire comprising two 7-item subscales: anxiety (HADS-A) and depression (HADS-D). Each item is scored from 0 to 3. Each subscale score ranges from 0 to 21, with higher scores indicating greater symptom severity.
Measured: postoperative day 1 and postoperative day 3.
Postoperative pain measured by Pain Numeric Rating Scale (NRS) score
Pain Numeric Rating Scale (NRS) score. The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Measured: 1 hour, 24 hours, 48 hours and 72 hours after surgery
Postoperative Quality of Recovery-15 (QoR-15)
Quality of Recovery-15 (QoR-15) score. The QoR-15 is a 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, and physical independence. Each item scored 0-10, total range 0-150, higher scores indicate better recovery quality.
Measured: Postoperative day 1
Postoperative delirium
Number of participants who develop postoperative delirium, assessed using the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM). The 3D-CAM is a structured instrument for delirium assessment.
Measured: Within 3 days after surgery (assessed twice daily)
Pittsburgh Sleep Quality Index (PSQI) Score at 1 Month After Surgery
Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a 19-item self-rated questionnaire assessing sleep quality over the past month. Seven component scores are summed to yield a global score ranging from 0 to 21. Higher scores indicate worse sleep quality.
Measured: 1 month after surgery
Parkinson's Disease Questionnaire-39 (PDQ-39) Score at 1 Month After Surgery
Parkinson's Disease Questionnaire-39 (PDQ-39) score. The PDQ-39 is a 39-item disease-specific quality of life questionnaire for Parkinson's disease. Scores are transformed to a 0-100 scale, with higher scores indicating worse quality of life.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903038
- Sponsor's protocol ID
- LEM2026-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: A Randomized, Double-blinded, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07903038
- Acronym / sponsor ID
- LEM2026-1
- Conditions
- Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders, Deep Brain Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests whether lemborexant, an approved sleep medicine, can improve sleep and recovery in people with Parkinson's disease undergoing deep brain stimulation (DBS) surgery. Sleep problems are common around surgery and may worsen pain and slow recovery. Participants will be randomly assigned to take lemborexant or a placebo the night before surgery. Researchers will compare anesthesia use, wake-up time, sleep quality (objective and subjective), pain, recovery, and blood markers. The study will show whether lemborexant is safe and helpful for this group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lemborexant 5 mg | Experimental | Drug: Lemborexant 5 mgParticipants will receive a single oral dose of lemborexant 5 mg tablet on the night before surgery. |
| Placebo | Placebo comparator | Drug: PlacaboParticipants will receive a single oral dose of matching placebo tablet on the night before surgery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Parkinson's disease scheduled for elective DBS surgery under general anesthesia
- Age 50-80 years
- ASA physical status I-III
- Preoperative sleep disturbance, defined as Pittsburgh Sleep Quality Index (PSQI) score > 5
- Signed informed consent
Key exclusion criteria (7 listed)
- Hoehn-Yahr stage ≥ 4
- Chronic use of sedative-hypnotic medications
- Acute psychiatric illness
- Severe sleep apnea, COPD, severe daytime sleepiness (Epworth Sleepiness Scale [ESS] ≥ 16), or history of narcolepsy and/or cataplexy
- Severe hepatic or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 5 mgParticipants will receive a single oral dose of lemborexant 5 mg tablet on the night before surgery. | Drug | Lemborexant 5 mg |
| PlacaboParticipants will receive a oral dose of matching placebo tablet on the night before surgery. | Drug | Placebo |
Primary outcome
Total Sleep Time (TST) on the Night Before Surgery
Time frame: Night before surgery
Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band 8) during the night before deep brain stimulation surgery. TST is defined as the total duration of sleep from sleep onset to final awakening, reported in minutes.
11 secondary outcomes
Perioperative subjective sleep quality
Time frame: Preoperative night (assessed at 8:00-10:00 AM on the day of surgery), Postoperative days 1-3 (assessed at 8:00-10:00 AM)
Postoperative objective sleep quality
Time frame: Postoperative night 1 and night 3 (20:00 to 08:00 next day)
Time to Extubation
Time frame: Immediately after surgery (single assessment)
Time to Awakening
Time frame: Immediately after surgery (single assessment)
Perioperative Anxiety Visual Analog Scale (VAS-A) Score
Time frame: Perioperative [Upon entry to the operating room (before induction of anesthesia) and 1 hour after surgery]
Postoperative Hospital Anxiety and Depression Scale (HADS) Score
Time frame: postoperative day 1 and postoperative day 3.
Postoperative pain measured by Pain Numeric Rating Scale (NRS) score
Time frame: 1 hour, 24 hours, 48 hours and 72 hours after surgery
Postoperative Quality of Recovery-15 (QoR-15)
Time frame: Postoperative day 1
Postoperative delirium
Time frame: Within 3 days after surgery (assessed twice daily)
Pittsburgh Sleep Quality Index (PSQI) Score at 1 Month After Surgery
Time frame: 1 month after surgery
Parkinson's Disease Questionnaire-39 (PDQ-39) Score at 1 Month After Surgery
Time frame: 1 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemborexant 5 mg and Placabo in people with Parkinson Disease (PD) and Sleep Initiation and Maintenance Disorders, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, PhD (+86 59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (TST) on the Night Before Surgery (time frame: Night before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.